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Aizu Olympus Co., Ltd. recalls Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary
Recalled November 29, 2023 · FDA recall Z-0332-2024 · Aizu Olympus
Hazard
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection · FDA Class II
Units
46 units
Sold at
Worldwide - US Nationwide distribution.
Description
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Product
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
Manufacturer(s)
Aizu Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →